Psychedelics, entheogens, entactogens and dissociative anaesthetics, and cannabis are the sole focus of David’s intellectual property, regulatory and commercial practice.
Driven by a strong personal commitment to responsible and effective access to psychedelics for improving, maintaining and promoting mental health, David supports pro bono initiatives by non-profit organizations to facilitate and expand access to psilocybin, MDMA and other psychedelics for Canadians, both within and separate from Canada’s prescription drug system under the Food and Drugs Act.
His clients include:
- Federal licence holders and applicants under Part J of the Food and Drug Regulations (restricted drugs, including LSD, psilocybin, DMT, MDMA and other ring-substituted amphetamines, mescaline, 2,5-substituted phenethylamines, and other psychedelics)
- Federal licence holders and applicants under the Cannabis Regulations and the Industrial Hemp Regulations
- Technology companies innovating in psychedelics and cannabis
- Other domestic and foreign participants in the psychedelics space and in the cannabis industry
David’s regulatory practice includes drafting applications for, interacting with Health Canada in respect of, and otherwise advised in relation to, activities under dealer’s licences for LSD, DMT, psilocybin, MDMA and other psychedelics, including international sale of psychedelics manufactured in accordance with Good Manufacturing Practices (GMP) as an active pharmaceutical ingredient in drug products for use in clinical trials. David also interacts with Health Canada in relation to complex regulatory points on Cannabis Regulations and Industrial Hemp Regulations licences.
David’s intellectual property practice includes drafting and prosecuting patent applications, assessing patentability of technology, validity of patents and potential patent infringement exposure. David also completed patent-related due diligence and manages multi-jurisdictional patent portfolios.
David’s commercial practice includes drafting, negotiating and advising on technology licensing agreements, supply agreements for psychedelics and cannabis, white label cannabis manufacturing agreements and other commercial relationships with a strong intellectual property and regulatory aspect.
David holds a PhD in biochemistry. His graduate-level education in structural biochemistry, synthetic organic chemistry, physical chemistry, plant biochemistry and natural products chemistry provides a strong technical background for advising clients working with psychedelics and clients working in Canada’s cannabis industry in relation to both intellectual property and regulatory law.
David is co-chair of BLG's National Psychedelics and Cannabis Focus Group.
Psychedelics
- Advising on, drafting and negotiating long-term international supply agreements and single event sale agreements for GMP psilocybin, other restricted drugs and psychoactive compounds that are not controlled substances, to be used in clinical and preclinical research.
- Drafting and interacting with Health Canada in respect of dealer’s licence applications under Part J of the Food and Drug Regulations, including for cultivation of fungi that biosynthesize psilocybin and for synthesis of multiple small-molecule controlled substances, and corporate structuring advice in relation to holding a dealer’s licence.
- Advising on intellectual property, regulatory compliance and commercial aspects of commercialization of LSD, 2C-B, DMT, psilocybin, MDMA and other restricted drugs by licensed dealers under Part J of the Food and Drug Regulations.
- Drafting and advice for patent applications related to small molecules, small molecule synthesis, formulations, biosynthesis and other aspects of the supply chain for restricted drugs and precursors to restricted drugs.
- Regulatory and intellectual property advice related to corporate transactions for corporations working in psychedelics.
- Advising on an international joint venture, including development of products including psilocybin.
- Advising on and drafting agreements for commercial relationships between a technology company and a retreat located in Jamaica for psilocybin product development and research.
- Advising on the impact of securities exchange listing requirements resulting from holding assets with international operations including activities with unregulated psilocybin.
- Advising on compliance of off-label clinical use of racemic ketamine and use of psilocybin under exemptions issued under subsection 56(1) of the CDSA for treatment of mental health conditions in multiple provinces.
- Advising on, drafting and negotiating agreements between academic institutions and licensed dealers under Part J of the Food and Drug Regulations.
- Advising on regulatory, intellectual property, commercial and corporate aspects to commercializing substrate and other inputs for cultivation of fungi.
- Advising on non-profit and charitable organization structuring and scope of charitable mandates in respect of advocacy, education and provision of access to psilocybin for medical purposes.
- Drafting and advising on proposed medical access regulations for psilocybin and other controlled substances.
- Advising multiple technology companies (domestic and foreign), including licensed dealers and applicants, in relation to:
- scope of activities under dealer’s licences under Part J of the Food and Drug Regulations, Part G of the Food and Drug Regulations, the Narcotic Control Regulations and the Precursor Control Regulations
- intellectual property licensing;
- patent rights, including drafting and filing patent applications in relation to chemical synthesis, formulations, use for therapeutic indications and dosage forms; and
- trade secrets.
- Advising on, drafting and negotiating long-term international supply agreements and single event sale agreements for GMP psilocybin, other restricted drugs and psychoactive compounds that are not controlled substances, to be used in clinical and preclinical research.
- Drafting and interacting with Health Canada in respect of dealer’s licence applications under Part J of the Food and Drug Regulations, including for cultivation of fungi that biosynthesize psilocybin and for synthesis of multiple small-molecule controlled substances, and corporate structuring advice in relation to holding a dealer’s licence.
- Advising on intellectual property, regulatory compliance and commercial aspects of commercialization of LSD, 2C-B, DMT, psilocybin, MDMA and other restricted drugs by licensed dealers under Part J of the Food and Drug Regulations.
- Drafting and advice for patent applications related to small molecules, small molecule synthesis, formulations, biosynthesis and other aspects of the supply chain for restricted drugs and precursors to restricted drugs.
- Regulatory and intellectual property advice related to corporate transactions for corporations working in psychedelics.
- Advising on an international joint venture, including development of products including psilocybin.
- Advising on and drafting agreements for commercial relationships between a technology company and a retreat located in Jamaica for psilocybin product development and research.
- Advising on the impact of securities exchange listing requirements resulting from holding assets with international operations including activities with unregulated psilocybin.
- Advising on compliance of off-label clinical use of racemic ketamine and use of psilocybin under exemptions issued under subsection 56(1) of the CDSA for treatment of mental health conditions in multiple provinces.
- Advising on, drafting and negotiating agreements between academic institutions and licensed dealers under Part J of the Food and Drug Regulations.
- Advising on regulatory, intellectual property, commercial and corporate aspects to commercializing substrate and other inputs for cultivation of fungi.
- Advising on non-profit and charitable organization structuring and scope of charitable mandates in respect of advocacy, education and provision of access to psilocybin for medical purposes.
- Drafting and advising on proposed medical access regulations for psilocybin and other controlled substances.
- Advising multiple technology companies (domestic and foreign), including licensed dealers and applicants, in relation to:
- scope of activities under dealer’s licences under Part J of the Food and Drug Regulations, Part G of the Food and Drug Regulations, the Narcotic Control Regulations and the Precursor Control Regulations
- intellectual property licensing;
- patent rights, including drafting and filing patent applications in relation to chemical synthesis, formulations, use for therapeutic indications and dosage forms; and
- trade secrets.
Cannabis
- Advising an international pharmaceutical company in relation to cannabis supply, regulatory compliance and dosage forms.
- Advising a national pharmacy chain in relation to cannabis supply, regulatory compliance and new product categories.
- Advising a natural health products company in relation to a processing and cultivation licence, and intellectual property.
- Advising multiple biotechnology companies in relation to research and processing licences under the Cannabis Regulations, dealer’s licences under the Narcotic Control Regulations and in relation to intellectual property protection.
- Providing ongoing regulatory advice to federal cannabis licence holders and to entities applying for licenses under the Cannabis Regulations, including on labelling and promotional restrictions.
- Providing regulatory and commercial input in the context of insolvency proceedings, including with associated commercial litigation.
- Advising a major software company, federal cannabis licence holders, provincial retail licence and permit holders, cannabis accessories vendors, clinics and other entities in relation to promotional activity regulated by the Cannabis Act, the Cannabis Regulations and provincial legislation.
- Advising on, drafting and negotiating multiple cannabis supply agreements, and cannabis plant intellectual property licenses, between cultivation licence holders, nursery licence holders and processing licence holders.
- Advising on, drafting and negotiating multiple white-label and co-packing agreements between cultivation licence holders, processing licence holders, and unlicensed entities holding intellectual property rights relevant to branding or manufacturing, including foreign entities holding intellectual property rights.
- Advising on transaction of hemp flowers between Industrial Hemp Regulations licence holders and cannabis processors.
- Advising food companies in relation to positioning for sale of edible cannabis, including both foods and beverages.
- Advising payment processors and other e-commerce businesses on compliance with the Cannabis Act and Cannabis Regulations for working with processing licence holders and medical sales licence holders.
- Advising multiple entities on obtaining retail sales licenses or permits in Alberta, British Columbia, Ontario and Saskatchewan.
- Drafting website terms and conditions and privacy policy and advising on online promotional activity for domestic and foreign federal cannabis licence holders, provincial retail licence and permit holders, social media sites and other industry participants.
- Advising multiple technology companies (domestic and foreign), including Cannabis Regulations licence holders, licensed dealers under the Narcotic Control Regulations (prior to the Cannabis Act) and applicants, in relation to:
- scope of activities under Cannabis Regulations licences, Marihuana Medical Access Regulations personal production licences extended by R v. Allard, and dealer’s licences under the Narcotic Control Regulations;
- intellectual property licensing;
- patent rights, including drafting and filing patent applications in relation to biotechnology and dosage forms;
- plant breeders’ rights; and
- trade secrets.
- Advising assisted living facilities in relation to the scope of practice of nurses outside of hospital, and in relation to adult-use policies.
- Advising on the scope of commercial and other activities that may be regulated by a First Nation in respect of cannabis outside of the Cannabis Act.
- Working with professionals in BLG's corporate and immigration groups to move skilled individuals into Canada to work in the cannabis industry.
- Advising federal cannabis licensees and other entities on the scope of wares and services that may be included in trademark applications to position for product diversification.
- Engaging the Government of Canada on behalf of federal licence holders to prepare submissions on regulations under the Cannabis Act and the Excise Act, and engaging with the Government of Québec about restrictions on cannabis concentrates.
- Advising an international pharmaceutical company in relation to cannabis supply, regulatory compliance and dosage forms.
- Advising a national pharmacy chain in relation to cannabis supply, regulatory compliance and new product categories.
- Advising a natural health products company in relation to a processing and cultivation licence, and intellectual property.
- Advising multiple biotechnology companies in relation to research and processing licences under the Cannabis Regulations, dealer’s licences under the Narcotic Control Regulations and in relation to intellectual property protection.
- Providing ongoing regulatory advice to federal cannabis licence holders and to entities applying for licenses under the Cannabis Regulations, including on labelling and promotional restrictions.
- Providing regulatory and commercial input in the context of insolvency proceedings, including with associated commercial litigation.
- Advising a major software company, federal cannabis licence holders, provincial retail licence and permit holders, cannabis accessories vendors, clinics and other entities in relation to promotional activity regulated by the Cannabis Act, the Cannabis Regulations and provincial legislation.
- Advising on, drafting and negotiating multiple cannabis supply agreements, and cannabis plant intellectual property licenses, between cultivation licence holders, nursery licence holders and processing licence holders.
- Advising on, drafting and negotiating multiple white-label and co-packing agreements between cultivation licence holders, processing licence holders, and unlicensed entities holding intellectual property rights relevant to branding or manufacturing, including foreign entities holding intellectual property rights.
- Advising on transaction of hemp flowers between Industrial Hemp Regulations licence holders and cannabis processors.
- Advising food companies in relation to positioning for sale of edible cannabis, including both foods and beverages.
- Advising payment processors and other e-commerce businesses on compliance with the Cannabis Act and Cannabis Regulations for working with processing licence holders and medical sales licence holders.
- Advising multiple entities on obtaining retail sales licenses or permits in Alberta, British Columbia, Ontario and Saskatchewan.
- Drafting website terms and conditions and privacy policy and advising on online promotional activity for domestic and foreign federal cannabis licence holders, provincial retail licence and permit holders, social media sites and other industry participants.
- Advising multiple technology companies (domestic and foreign), including Cannabis Regulations licence holders, licensed dealers under the Narcotic Control Regulations (prior to the Cannabis Act) and applicants, in relation to:
- scope of activities under Cannabis Regulations licences, Marihuana Medical Access Regulations personal production licences extended by R v. Allard, and dealer’s licences under the Narcotic Control Regulations;
- intellectual property licensing;
- patent rights, including drafting and filing patent applications in relation to biotechnology and dosage forms;
- plant breeders’ rights; and
- trade secrets.
- Advising assisted living facilities in relation to the scope of practice of nurses outside of hospital, and in relation to adult-use policies.
- Advising on the scope of commercial and other activities that may be regulated by a First Nation in respect of cannabis outside of the Cannabis Act.
- Working with professionals in BLG's corporate and immigration groups to move skilled individuals into Canada to work in the cannabis industry.
- Advising federal cannabis licensees and other entities on the scope of wares and services that may be included in trademark applications to position for product diversification.
- Engaging the Government of Canada on behalf of federal licence holders to prepare submissions on regulations under the Cannabis Act and the Excise Act, and engaging with the Government of Québec about restrictions on cannabis concentrates.
